FDA Provides Seven Years of Orphan-Drug Exclusive Approval for Ryoncil®

FDA Provides Seven Years of Orphan-Drug Exclusive Approval for Ryoncil®

Mesoblast announced that it has received seven years of orphan-drug exclusive approval from US FDA for Ryoncil® for treatment of steroid-refractory acute graft versus host disease in pediatric patients 2 months of age and older. [Mesoblast (BioSpace)] Press Release

FDA Grants Orphan Drug Exclusivity to Mesoblast's Ryoncil for Pediatric GVHD

Ryoncil is the first mesenchymal stromal cell therapy to be approved in the United States.

FDA grants fast track status to Zai Lab's lung cancer treatment

This ADC, which is currently under assessment in a global Phase Ia/IIb trial, has secured orphan drug designation from the agency for SCLC. According to the company, SCLC The post FDA grants fast track status to Zai Lab’s lung cancer treatment appeared first on Pharmaceutical Business review.